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The Environmental Protection Agency has been regulating more new chemicals since the
Toxic Substances Control Act was overhauled than it did before, according to a snapshot
of its work over the past 11 months.

“It’s definitely harder to get a new chemical to market,” Charles Auer, a former senior
EPA chemicals official told Bloomberg BNA. Auer now is a senior regulatory and policy
adviser for the Bergeson & Campbell, P.C. law firm.

Auer, who spent 32 years working on chemicals at EPA, said he had expected the new
law to double or triple the number of regulations the agency would impose on new chemicals,
Instead the agency’s regulation rate is vastly exceeding his expectations.

Prior to the law’s update, about 10 percent of new chemicals were regulated in some
way, Auer said. A snapshot of information the EPA released May 17 suggests about 50
percent of new chemicals are being regulated since TSCA was amended, he said.

Chemical Makers Withdrawing Requests

As the rate of regulation increases, chemical manufacturers are withdrawing more requests
to make new chemicals than they did before the statute was revised, Dan Newton, a
senior government relations manager with the Society of Chemical Manufacturers &
Affiliates, told Bloomberg BNA.

Historically, companies withdrew about 5 percent of the new chemical requests they
submitted to the agency, Auer said. The agency’s latest information suggests companies
are withdrawing about 25 percent of their requests to make new chemicals, called premanufacture
notices or PMNs, he said.

The increased rate of regulations combined with more manufacturers withdrawing their
applications to make new chemicals may keep older chemicals, which traditionally raise
more health and environmental concerns, on the market.

Liz Hitchcock, legislative director for the Safer Chemicals Healthy Families, thinks
the EPA’s more stringent new chemical reviews are good.

One of the reasons the public was frustrated by TSCA–prior to its amendment in June
2016—is that new chemicals got very little oversight before they entered commerce,
Hitchcock said.

EPA’s increased scrutiny “will build confidence in the agency’s ability to protect
the public from toxic chemicals,” she said.

EPA Data

Auer, Hitchcock and Newton shared their insights regarding information the EPA provided
Bloomberg BNA summarizing its new chemicals actions since TSCA was amended by the
Lautenberg Chemical Safety Act on June 22, 2016. According to the EPA’s summary:

Between June 22, 2016, and May 9, the agency has allowed 255 new chemicals, new microbes
or new uses of chemicals to enter commerce.

Of these 255 cases, the agency determined that 84 new chemicals, microbes or chemical
uses are “not likely to present an unreasonable risk.” That’s the safest conclusion
the agency can make under the amended statute.

Of the 255 cases, the agency decided 171 raised concerns or questions that could
be addressed through consent orders negotiated between the company that submitted
the new chemical notice and the EPA.

As of May 9, 86 requests to make new chemicals or use chemicals in new ways had been
withdrawn since the law was amended; 74 new chemical or new use notices had been sent
back to the company that submitted them due to insufficient or invalid information.

Reducing Backlog

The EPA’s data also show that it has reduced its “backlog” of new chemicals that has
built up since the Lautenberg Act’s amendments became law. The term “backlog”
is shorthand for the greater than normal number of PMNs and other new chemical requests
under the agency’s review since TSCA was amended.

As of May 9, 481 new chemicals or new chemical use notices were under review, the
EPA said in response to emailed questions from Bloomberg BNA.

Historically, EPA has tended to have about 300 new chemicals under review at any given
time, the agency said. With 481 new chemicals notices under review, that means the
office has a “backlog” of 181 cases.

“EPA has revised and streamlined its process, brought in new staff to help in the
reviews and is making progress in reducing the backlog of chemicals in the pipeline
for review,”
the agency said.

Cal Dooley, president of the American Chemistry Council, addressed the backlog issue
in an April insights article he wrote for Bloomberg BNA.

At that time, the backlog of new chemicals awaiting the agency’s approval had doubled
from 331 to 658 since passage of the amended law, Dooley wrote. Available information
at the time had suggested the agency had approved only 33 substances since TSCA was
amended, which he said was “a sharp decline for a program that has historically reviewed
about 1,000 substances every year.”
The chemistry council represents U.S. chemical manufacturers including 3M, Arkema,
Inc., the BASF Corp., ExxonMobil Chemical Co., and LyondellBasell Industries Holdings
B.V.

Innovation

Auer, Hitchcock, Newton and Dimitrios Karakitsos, a partner with Holland &
Knight LLP’s Washington, D.C., office, agreed the agency’s information shows it is
making progress to speed its reviews of new chemicals.

“The folks at the EPA are righting the ship,” said Karakitsos, who previously served
as counsel to the Republicans on the Senate Environment and Public Works Committee.
In that role, he served as a principal drafter and negotiator of the amended chemicals
law.

The progress to date shows EPA Administrator Scott Pruitt’s commitment to lead an
agency that follows the law Congress wrote, Karakitsos said.

Democrats and Republicans supported the Lautenberg Act with the understanding from
the EPA that the changes lawmakers were making to the agency’s new chemicals oversight
would allow U.S. chemical manufacturers to continue innovating, he said.

“Maintaining robust innovation was a huge priority in both the House and the Senate,”
Karakitsos said.

“New chemicals are generally greener, more environmentally friendly and less toxic,”
he said. All sides have an interest in a predictable process that allows the products
of innovation to get to market.

Trend Encouraging Older Chemicals?

Auer said his experience at the EPA, which included directing the agency’s chemicals
office, Office of Pollution Prevention and Toxics, taught him that chemistry is improved
slowly over time.

“Most chemical developments occur through relatively small tweaks,” he said. Companies
adjust some portion of a molecule, he said. That adjustment produces significant improvements
in performance while reducing toxicity and saving money through means such as reduced
energy use, waste generated or other environmental benefits, Auer said.

Hence, Auer and Newton said they were concerned by the agency’s increased regulation
of new chemicals.

“It’s ironic there’s so much focus on restricting new chemicals,” because the problems,
Newton said.

A consequence of increased regulation of new chemicals, Auer said, is that the companies
that purchase chemicals to make products continue to use existing chemicals.

To contact the reporter on this story: Pat Rizzuto in Washington at
prizzuto@bna.com

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